Using Oasis ECM to treat donor site wounds

Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds

This study is testing if a new treatment called Oasis ECM can help heal donor site wounds better than regular wound care for people over 16 in the UK.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Cook Biotech Incorporated (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Manchester, England)
• Trial ID: NCT04079348 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Oasis extracellular matrix (ECM) for treating donor site wounds in patients over 16 years old in the United Kingdom. Approximately 40 participants will be enrolled, with half receiving Oasis ECM and the other half receiving standard wound care. The study aims to assess how well Oasis ECM promotes healing in comparison to conventional methods. Participants must have a specific type of skin graft donor site wound that requires a covering material.

Who should consider this trial

Good fit: Ideal candidates are individuals over 16 years old with a split thickness skin graft donor site wound no larger than 14 x 20 cm.

Not a fit: Patients with significant co-morbidities that impair wound healing or those under 16 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance healing outcomes for patients with donor site wounds.

How similar studies have performed: While Oasis ECM is commercially available, this specific application for donor site wounds is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

1. Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.
2. Has at least 24 hours to consent to study participation.

Exclusion Criteria:

1. Age \< 16 years
2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:

   1. Chronic inflammatory skin condition
   2. Chronic liver failure
   3. Chronic renal failure
   4. Blood-borne viruses (Hep B, Hep C, HIV)
   5. Peripheral vascular disease
   6. Clinically significant anaemia
   7. Uncontrolled diabetes
3. Need for use of the same harvest site (re-cropping)
4. History of radiation therapy to proposed donor site
5. Chronic use of medications known to impair wound healing
6. Chronic use of opioids or neuropathic pain agents
7. Suspected cellulitis, osteomyelitis or septicaemia
8. Patients undergoing haemodialysis
9. Patients requiring spinal/regional block
10. Patients on current anti-coagulant therapy
11. Unable or unwilling to provide informed consent
12. Unable or unwilling to comply with the study follow-up schedule, and procedures
13. Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study)
14. Allergy or hypersensitivity to materials that are porcine-based
15. Cultural or religious objection to the use of pig or porcine products
16. Known intolerance/allergy to standard wound care products
17. Presence of a local infection at the donor site and/or systemic infection

Where this trial is running

Manchester, England

• Manchester University NHS Foundation Trust — Manchester, England, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Carina Gregory, MS

Conditions Surgical Wound; Wound; Wounds and Injuries; Wound Heal; Donor Site Wound